Advia Centaur CP System- B-Type Natriuretic Peptide (BNP) Assay (2014-03-24)

Starting date:

March 24, 2014

Posting date:

July 7, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-40393

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  Reason
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  Affected products

Recalled Products

Advia Centaur CP System- B-Type Natriuretic Peptide (BNP) Assay

Reason

Siemens Healthcare Diagnostics has received complaints of failed calibrations on the Advia Centaur CP system when using BNP kit lots ending in 172. Siemens has confirmed that the failed calibration is due to an error on the Advia Centaur CP master curve card. The master curve card error results in a low calibration deviation outside the specified calibration evaluation range when using kit lots ending in 172 on the Advia Centaur CP only. An invalid calibration status will prevent BNP results from being generated. The master curve card contained in kit lots ending in 172 for the Advia Centaur and Advia Centaur XP platforms is not impacted and there is no calibration issue when using BNP kit lots ending in 172 on those systems.

Affected products